Eli Lilly announces Xigris clinical trial

Eli Lilly has announced pans for a clinical trial of Xigris (drotrecognin alfa [activated]). The aim of this trial will be to better identify patients with severe sepsis for whom this compound may provide a novel treatment option, in addition to clarifying the benefit and risk profile of the drug.

Xigris is a recombinant form of activated protein C found in the body that is administered to patients by an intravenous infusion in 5 mg or 20 mg doses.

The compound was licensed for use in the European Union in August 2002, with the Committee for Medicinal Products for Human Use annually reviewing the data regarding the compound.

J Anthony Ware, vice president of Lilly Research Laboratories and global platform leader for cardiovascular and acute care, said: “Advancements made in sepsis care over the past five years and ongoing scientific questions surrounding appropriate patient selection for Xigris and about severe sepsis treatment in general make this an opportune time for a new phase III placebo-controlled study of Xigris.”

He added that the forthcoming study could provide additional scientific insight into the compound in addition to potential benefits to patients.

Last October, Lilly announced the initiation of a phase III clinical trial of Alimta (pemetrexed for injection) in patients with small cell lung cancer.